insert presentation name here - uniklinik-freiburg.de · insert presentation name here 5/22/2015 2...

Insert presentation name here

5/22/2015

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1© Copyright 2014 Quintiles

Jochen ZeschkyDirector, Site & Patient Networks, Western Europe20th May 2015

Ohne Patienten keine StudienWie geht eine CRO an dieses Thema heran?

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It’s a Great Time to be a Patient!

From a patient’s perspective things have never look ed brighter.

Never were more drugs under development; with incre asing our

knowledge many patients have access to better care.

More treatments than ever available


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FDA - 2014 Novel New Drugs Summary

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• Innovative approaches are changing the treatment paradigm in oncology, e.g.,

› Converting cancer into a “chronic disease”

› Prevention of cancer through, e.g., vaccination

› Pathway related treatments

• The pathophysiology of neuropsychiatric and neurodegenerative disorders will become more apparent and allow for more targeted treatments, e.g.,

› Receptor imaging as a further diagnostic tool supporting early detection

› Nanotechnology as a part of a targeted therapy

Science Drives New Treatments

Deep insights in underlying mechanisms allow for mo re targeted therapies


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Personalized Medicine is Coming

Translational Medicine translates deep insights fro m biological discoveries into tailor-made drugs and medical devices

Targeted therapies will drive the future growth of medical therapies

Classic MedicineAll patients receive the same therapy

Personalized MedicinePatients are prescreened

to identify responders

Equal efficacy AE / worse efficacyImproved efficacy

CompanionDiagnostics Biomarkers

Targeted Therapies

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Demonstrating product value with more ‘real life’ data of central importance in this environment

Nevertheless, Value Has to Be ProvenDemonstration of healthcare value drives market adoption

“Old Paradigm” “New Paradigm”

• Quality

• Safety

• Efficacy

• Quality

• Safety

• Efficacy

• Value


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Drug DevelopmentCost Explosion

10,000 to 1

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Janet Woodcock, Center for Drug Evaluation and Research, FDA

Each time a new drug is tested, the process is repeated, at great expense, only to dismantle the infrastructure

when the study is completed. We believe that there areways to greatly improve clinical trial efficiency, such as

widespread use of clinical trial networks and masterprotocols…..


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• The Patient is „Center stage“

• What are a Patients needs?

• What does the Patient think?

Patient CentricityTurning the Industry on its Head

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Patient centricity is remembering why we do what we

do, it is not about developing a drug; it’s about helping

patients and bringing much needed therapies to them.

There are many ways of demonstrating patient

centricity - with one being ensuring that patients

know what their options are for their care,

including participation in clinical trials.


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Recruitment Strategies

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Recruitment StrategyRecruiting the most qualified patients as cost effectively as possible

Site Recruitment

Qua

lifie

d P

atie

nts

Cost

Site Recruitment

Patient PreID Recruitment Tools


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Educate and Recruit the “right” Patient

Over 50% of sites use brochures to recruit patients and approximately 40% use ICF

tools. A well-informed patient is more likely to be compliant and committed to the

study.

Study brochures and ICF tools

Highlight study benefits in recruitment tools.

Members of Quintiles patient communities have told us that comprehensive evaluations, medication, supplies, diet and exercise counseling, as well as advancing research, are benefits of study participation

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Recruitment Strategy


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EpocratesPhysician Outreach


Site Recruitment

Physician Referrals

Qua

lifie

d P

atie

nts

Cost

Site Recruitment

Physician Referrals


Outreach to Referral Partners

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• Pharmacies developing their Primary Care role

• Pharmacy Outreach – educating and engaging patients for studies in the Pharmacy

• Patients collecting repeat prescriptions can be flagged for a particular study

• Simple diagnostic procedures done at the pharmacy (BP, travel vaccine etc.)

• Crucial that the site staff are dialled in to receive the subjects via the pharmacy

Pharmacy outreach... for certain studies


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• Picking several patients for your panel

• Used successfully in Bio-banking

• No particular medical background

• Trained on the 4 key talking points to

engage fellow patients in Research

• Target patients waiting in the outpatient

clinic for their appointment

• Ask patients to sign a pledge to support

cancer research at the clinic

The advocate patient

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EpocratesPhysician Outreach


Site Recruitment

Physician Referrals

Patient Outreach

Qua

lifie

d P

atie

nts

Cost

Site Recruitment

Physician Referrals

Community Outreach

Site AdvertisingMedia Planning /Mgmt

Digital Patient Outreach and Referral


Outreach to Referral Partners

Digital outreach is a component of the recruitment

strategy


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Everything is changing!

Patients (knowledge), Sites (definition), Studies (complexity)... Taking the study to the patient!

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Patients are online — and eager to help


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A little digital context...

• We talk about digital like it is something new - Google is 15+ years old, Facebook is 10 and Twitter is 8...

• Regarding social interaction and conventions, Zuckerberg has changed overnight that which took society over 400 years to establish...

• A downside is beginning to become apparent – Prism & Edward Snowden, Facebook trolling, Twitter bullying, phishing scams etc.

• JPMorgan Chase cancelled question and answer session on Twitter after being flooded with insults, highlighting risks companies take as they experiment with social media marketing

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Accelerate Adoptionand Build Adherence

Enhance Feasibility

Streamline Recruitment

Drive Retention

The Digital Difference

Accelerate Adoption

Strengthen Patient Adherenceand Loyalty

Enhance Product Positioningand Differentiation

Collect Real-World DataDirectly from Patients

Validate and Aggregate Data

Follow Up with Patients Virtually

Streamline ProductDevelopment

Prove Product Value and Safety

How digital patient engagement is transforming the industry


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Patient insights for study designCollect direct patient feedback to better understand needs, beliefs and behaviors (Patient Centricity)

• Your condition...

• Your medication...

• Your other symptoms...

• Your needs andpreferences...

• Why would you join a study?...

Insightsgatheringapproach

Outreach toPatient communities and digital universe

Analysisand report (PDAT)1 2 3

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Pre-recruitment communities for research

Pre-recruit and qualify patients at presentation and looking at trials as treatment options

Collect data directly from lung cancer patients whi le in the community via ePRO, survey, call centre, mobile and digital health devices to build your patient profile evidence and recruit fro future clinical studies

Pre-recruitment community

Future clinical study

Pre-qualify patients in geo-targetedlocations over time

Transition pre-qualified patients to sites for recruitment

Maintain long-term relationships to connect with other research

Direct-to-patient recruitment

and registration


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The virtual study pathway

Technology exists for a virtual study however, there are certain areas in the study process that require further research to find the best solution for a successful study

Video

AudioPatients

InterestedIn Trial

WebcastWeb Portal

Data Aggregation

Electronic Appointment Reminders

Physicians/HCPs

Study Patients

ScreeningEnrollmentConsent

Identity Verification

Paper Chart Reviewer

Incentives

Incentives

SocialMedia

A future model?

An interactive digital solution

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Innovation & Retention


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• New digital innovations require industry to work differently with Sites

• We can not work with a site the same way we did 20 years ago!

• Rather than “push” patients to the clinic through advertising – we are now “pulling” and “retaining” them through Research Nurse engagement

Industry & Clinics together in the engagement of research patients

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• Engaging and educating patients at point of care (outpatients)

• On-boarding touch screen

• Linking to eMR in the back office flagging patients for studies

• Rolling patient education “infomercials” on the clinic Plasma Screen

• Study specific patient education tools

• App messaging

The connected clinic


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• Useful tool across the board, explaining complex protocols simply

• Interactive, touch screen technology

• Built in comprehension algorithms

• 87% of key information common across studies, costs can come down

• More intuitive logic flow than paper

Informed consent animations

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• Clinic visit reminders

• Motivational messages

• Supporting complex regimens/cyclical dosing

• Tracing “Lost to follow-up” patients

• Helpful in long duration studies or multiple

visits

• E-diaries

- Mobile Phone based

- Provides simple data collection tool

• Supporting dynamic consent process

Dynamic SMS consent and motivation

Would youLike to updateYour consent?

YES No


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Rules of Engagement for Consideration• Recruitment

› Plan strategy ahead of the study. Who? What? When?

› Conduct eMR review for potential patients (Feasibility)

› What Partners do I have?

› Social media analysis tools (mapping the geographic distribution of patient populations and scanning social media activity relative to your clinic) Geographical reference!

› Have the resource available to engage patients coming through the various channels

• Retention / Motivation› Use of tablets by subjects as part of clinical trial (gamification)

› SMS text message reminders,

› Adaptation of web based compliance tactics for study compliance (surveys, sms etc)

Digital tactics are only as good as the willingness and investment in the site staff in converting referrals into screened & rando mised patients

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THANK YOUFOR YOUR ATTENTION

[email protected]


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External Public &

CommercialData

SponsorData

Investigator PrimaryResearch

Patient Primary

Research

QuintilesCountry and

Medical Experts

Internal Proprietary

Data

Quintiles study

specific,data driven approach

The Quintiles protocol feasibility approach

• Direct to investigator surveys• Focus groups & discussion forums• Interviews

Leveraging all existing data that Quintiles has (e.g. number of investigators, performance metrics by country/site)

Online direct to patient surveys

Medical, operational, and local review of protocol, materials

Comprehensive mining of publically available data as well as subscription services that Quintiles purchases

• Current development plans• Protocol synopsis• Sponsor-recommended KOLs• Research undertaken to date

Data examples include:• Competing trials• Patient populations and how

they may meet inclusion/exclusion criteria

• Incidence/prevalence• Standard of care and drug

usage• Literature reviews

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